Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study (CHOICE2)
Primary Purpose
Heart Failure, Cardiac Resynchronisation Pacemakers
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optimisation of VV delay
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Pacemakers
Eligibility Criteria
Inclusion Criteria:
- Cardiac Resynchronization Device in situ for Heart Failure
Exclusion Criteria:
- Unable to cope with mouthpiece
- Estimated life expectancy < 6 months
Sites / Locations
- University of Dundee
Outcomes
Primary Outcome Measures
6 minute hall walk test
Secondary Outcome Measures
Echocardiographic measures of desynchrony
Full Information
NCT ID
NCT01055210
First Posted
January 22, 2010
Last Updated
November 29, 2018
Sponsor
University of Dundee
1. Study Identification
Unique Protocol Identification Number
NCT01055210
Brief Title
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
Acronym
CHOICE2
Official Title
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronisation Pacemakers
Keywords
Heart Failure, Pacemakers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Optimisation of VV delay
Intervention Description
Programmed VV delay altered on device
Primary Outcome Measure Information:
Title
6 minute hall walk test
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Echocardiographic measures of desynchrony
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiac Resynchronization Device in situ for Heart Failure
Exclusion Criteria:
Unable to cope with mouthpiece
Estimated life expectancy < 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna- Maria Choy
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dundee
City
Dundee
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
We'll reach out to this number within 24 hrs